Quantitative Fluorescence Molecular Imaging of Ustekinumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Crohn's Disease and Psoriasis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ustekinumab.
- Who it may be relevant to
- Registry conditions: Psoriasis, Crohn Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Quantitative Fluorescence Molecular Imaging of Ustekinumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Crohn's Disease and Psoriasis: a Prospective Pilot Intervention Study
Overview
Crohn's Disease (CD) and psoriasis are chronic inflammatory diseases. Ustekinumab is a humanized monoclonal antibody. Ustekinumab is expensive and primary non-response is high in both CD and psoriasis. Currently, there are no predictors of response to ustekinumab and the actual mechanism of action has not yet been elucidated. To clarify the mechanism of action and gain a better understanding of the high primary non-response rates, the University Medical Center Groningen (UMCG) developed a tracer fluorescently labeling ustekinumab. This study aims to gain insight into ustekinumab distribution and concentrations in the gut. The current study aims to identify the ustekinumab target cells in the inflamed gut mucosa and skin using quantitative fluorescence molecular endoscopy (qFME). By gaining insight into local ustekinumab concentrations, drug distribution, and by discovering target cells, we expect to gain insight into the mechanism of action of ustekinumab.
Interventions
- Drug Ustekinumab
Patients not on therapy and patients on therapy will undergo fluorescence molecular imaging.
Primary outcome measures
- Quantification of fluorescent signal of fluorescent ustekinumab in CD and psoriasis patients. [Time frame: 3-4 days after tracer admission]
Eligibility criteria
Inclusion criteria
- Established diagnosis of CD or PsO
- Non-responsive to conventional therapy
- Active disease:
- CD cohort: clinically active disease of the bowel defined either clinically as at least moderate activity using dedicated scoring indices (for definitions of disease activity, see below) or biochemically active disease as defined by a faecal calprotectin > 200 ug/g;
- PsO: clinically active disease of at least PASI ≥ 10 or clinically active disease as assessed by a dermatologist;
- Age ≥ 18 years;
- Written informed consent.
Exclusion criteria
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent according to treating medical physician;
- Prior ustekinumab treatment within the last 15 weeks (except for patients in the treatment arm and control group);
- Ustekinumab contraindicated as therapy;
- Pregnancy or breast feeding. A negative pregnancy test must be available for women of childbearing potential (i.e. premenopausal women with intact reproductive organs and women less than two years after menopause);
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Other
Study locations
Netherlands · 1 center
- University Medical Center Groningen — Groningen
Publications
- Gabriels RY, van der Waaij AM, Linssen MD, Dobosz M, Volkmer P, Jalal S, Robinson D, Hermoso MA, Lub-de Hooge MN, Festen EAM, Kats-Ugurlu G, Dijkstra G, Nagengast WB. Fluorescently labelled vedolizumab to visualise drug distribution and mucosal target cells in inflammatory bowel disease. Gut. 2024 Aug 8;73(9):1454-1463. doi: 10.1136/gutjnl-2023-331696. PMID 38580386
Identifiers
NCT: NCT05725876 · 83371